Verrica Pharmaceuticals announces CHMP support for Ycanth MAA filing

Verrica Pharmaceuticals (VRCA) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has provided feedback that supports the filing of a marketing authorization application for Verrica’s product, Ycanth, as a treatment for molluscum contagiosum. The company sought and received written feedback from the CHMP to gain scientific advice on the development of Ycanth for the treatment of molluscum in adult and pediatric patients 2 years of age and older. The key issues discussed in the feedback included alignment on: the acceptability of the design of the previously-completed Phase 3 studies, including study duration, choice of primary and secondary endpoints and the choice of patient population; the clinical safety data package to support MAA filing and the adequacy of nonclinical studies and published literature to support the MAA filing. “We are pleased to gain alignment with CHMP with respect to the safety and efficacy data requirements to support an MAA filing for YCANTH in the European Union,” said Jayson Rieger, president and CEO of Verrica. “Based on convincing efficacy data from the well-controlled Phase 3 studies successfully conducted in both the U.S. and Japan, the CHMP concluded that no further Phase 3 clinical studies are needed in order to progress toward a filing for approval. The European market for molluscum represents a significant unmet need for millions of potential patients, and this feedback provides Verrica with a key catalyst to explore a broad range of strategic opportunities for realizing the full commercial potential of YCANTH and to treat patients with molluscum in this large and underserved market.”